Expandable device delivery

ABSTRACT

An expandable device can be delivered to a luminal structure in a patient using a delivery system. The delivery system can include an elongate carrier member and an engagement component that can releasably engage the expandable device. The elongate carrier member can have a distal portion, a central axis, and a first notch in the distal portion. The engagement component can be positioned within the first notch. Further, the expandable frame can be coupled to the distal portion of the carrier member and have a first terminal end section. When coupled to the carrier member, the first terminal and section can (i) pass from a first end of the first notch through a space between the central axis and the engagement component and (ii) terminate outside of the first notch, beyond a second end of the first notch.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/906,993, filed on Oct. 18, 2010, the entirety of each of which isincorporated herein by reference.

BACKGROUND

1. Field of the Inventions

The present invention generally relates to methods and devices fordelivering an expandable member to a luminal structure in a patient.

2. Description of the Related Art

Devices exist for stenting luminal structures in patients. Stentstypically maintain patency in luminal structures such as blood vessels.As a result, flow of fluid such as blood through the luminal structuresis generally maintained.

SUMMARY

Problems associated with typical devices for occluding flow throughluminal structures of patients include inaccurate positioning andengagement of these devices within the luminal structures, as well ashaving continuous and significant residual flow. These devices, onceplaced, do not provide mechanisms allowing for their repositioningand/or removal in a simple manner. Thus, once these devices have beenplaced, the devices are typically committed to their initially placedpositions. It is therefore desirable to provide devices that can be usedto reduce or stop flow through a luminal structure in a patient, andalso allow for their repositioning and/or removal.

According to various embodiments of the subject technology, a device isprovided for delivering an expandable member to a luminal structure in apatient. The device comprises a carrier member, positionable in aluminal structure in a patient and having a cross-sectional area. Thecross-sectional area comprises a first half and a second half that areseparated by a line segment. The line segment intersects a point along acentral long axis of the carrier member. The carrier member further hasa carrier lumen extending axially at least partially through the carriermember and intersecting solely the first half of the cross-sectionalarea. The device also comprises a first notch in the carrier member,wherein, when the carrier member is positioned in the luminal structure,the carrier lumen is in fluid communication with a body fluid in theluminal structure at the first notch. The device comprises an elongatemember that extends through the carrier lumen across the first notch,and an expandable member configured to expand within and engage theluminal structure and to be carried by the carrier member, and having afirst portion that fits within the first notch. When the elongate memberextends through the carrier lumen and across the first notch, theelongate member secures the first portion to the carrier member. Whenthe first portion is secured to the carrier member, the first portionintersects solely the first half. The elongate member is configured tomove axially through the carrier lumen such that the elongate memberpermits release of the first portion from the carrier member andexpansion of at least part of the expandable member.

In some embodiments, the elongate member is configured to be refractedby an operator such that the elongate member permits the release of thefirst portion. In some embodiments, the elongate member permits therelease of the first portion when the elongate member does not fullyextend across the first notch. In some embodiments, the elongate membercomprises a wire. In some embodiments, when expanded within and engagingthe luminal structure, the expandable member substantially reduces flowof the body fluid through the luminal structure. In some embodiments,the expandable member fully obstructs flow of the body fluid through theluminal structure. In some embodiments, the expandable member ishelically arranged about the carrier member. In some embodiments, theexpandable member is coiled around the carrier member before beingreleased from the carrier member.

In some embodiments, the device further comprises a catheter throughwhich the carrier member moves when positioned within the luminalstructure. In some embodiments, when the elongate member secures thefirst portion to the carrier member, the elongate member lies exteriorto the first portion relative to the central long axis of the carriermember.

According to certain embodiments, the device further comprises a secondnotch in the carrier member. When the carrier member is positioned inthe luminal structure, the carrier lumen is in fluid communication witha body fluid in the luminal structure at the second notch. The elongatemember extends through the carrier lumen across the second notch. Theexpandable member comprises a second portion that fits within the secondnotch. When the elongate member extends through the carrier lumen andacross the second notch, the elongate member secures the second portionto the carrier member. When the second portion is secured to the carriermember, the second portion intersects solely the first half. Theelongate member is configured to move axially through the carrier lumen,after the first portion is released from the carrier member, such thatthe elongate member permits release of the second portion from thecarrier member and release of the expandable member from the carriermember. In some embodiments, when the elongate member secures at leastone of the first portion and the second portion to the carrier member,the elongate member lies exterior to at least one of the first portionand the second portion relative to the central long axis of the carriermember.

According to various embodiments of the subject technology, a method fordelivering an expandable member to a luminal structure in a patient isprovided. The method comprises positioning a carrier member in a luminalstructure in a patient. The carrier member has a cross-sectional areacomprising a first half and a second half that are separated by a linesegment intersecting a point along a central long axis of the carriermember. The carrier member further has a carrier lumen extending atleast partially through the carrier member and intersecting solely thefirst half. The carrier member has a first notch. When the carriermember is positioned in the luminal structure, the carrier lumen is influid communication with a body fluid in the luminal structure at thefirst notch. An elongate member extends through the carrier lumen acrossthe first notch. An expandable member is carried by the carrier memberand includes a first portion that fits within the first notch. Theexpandable member is configured to expand within and engage the luminalstructure. When the elongate member extends through the carrier lumenand across the first notch, the elongate member secures the firstportion to the carrier member. When the first portion is secured to thecarrier member, the first portion intersects solely the first half. Themethod also comprises moving the elongate member axially through thecarrier lumen such that the elongate member permits release of the firstportion from the carrier member and expansion of at least part of theexpandable member.

In some embodiments, the moving comprises retracting the elongate memberby an operator who is performing the retracting. In some embodiments,the elongate member permits the release of the first portion when theelongate member does not fully extend across the first notch. In someembodiments, the expandable member is helically arranged about thecarrier member. In some embodiments, the expandable member is coiledaround the carrier member before being released from the carrier member.In some embodiments, when the elongate member secures the first portionto the carrier member, the elongate member lies exterior to the firstportion relative to the central long axis of the carrier member. In someembodiments, the elongate member comprises a wire.

According to certain embodiments, the method further comprises movingthe carrier member through a catheter when positioning the carriermember within the luminal structure.

According to certain embodiments, the method further comprisessubstantially reducing, with the expandable member, flow of the bodyfluid through the luminal structure when the expandable member isexpanded within and engaging the luminal structure. In some embodiments,the method further comprises fully obstructing, with the expandablemember, flow of the body fluid through the luminal structure when theexpandable member is expanded within and engaging the luminal structure.

According to certain embodiments, the carrier member further comprises asecond notch. When the carrier member is positioned in the luminalstructure, the carrier lumen is in fluid communication with a body fluidin the luminal structure at the second notch. The elongate memberextends through the carrier lumen across the second notch. Theexpandable member comprises a second portion that fits within the secondnotch. When the elongate member extends through the carrier lumen andacross the second notch, the elongate member secures the second portionto the carrier member. When the second portion is secured to the carriermember, the second portion intersects solely the first half. The methodfurther comprises moving, after the first portion is released from thecarrier member, the elongate member axially through the carrier lumensuch that the elongate member permits release of the second portion fromthe carrier member and release of the expandable member from the carriermember. In some embodiments, when the elongate member secures at leastone of the first portion and the second portion to the carrier member,the elongate member lies exterior to at least one of the first portionand the second portion relative to the central long axis of the carriermember.

According to various embodiments of the subject technology, a device fordelivering an expandable member to a luminal structure in a patient isprovided. The device comprises a carrier member, positionable in aluminal structure in a patient and having a carrier lumen extendingaxially at least partially through the carrier member. The carrier lumenis bounded by a boundary having a boundary cross-sectional shape. Thedevice also comprises a first notch in the carrier member, wherein, whenthe carrier member is positioned in the luminal structure, the carrierlumen is in fluid communication with a body fluid in the luminalstructure at the first notch. The boundary has a first discontinuity atthe first notch, between a first boundary end and a second boundary end.The device comprises an elongate member that extends through the carrierlumen and across the first notch. A first projection, having across-sectional shape that is substantially the same as the boundarycross-sectional shape, extends from the first boundary end, across thefirst discontinuity, to the second boundary end. The device comprises anexpandable member configured to expand within and engage the luminalstructure and to be carried by the carrier member, and having a firstportion comprising a first free end. The first portion fits within thefirst notch. In some embodiments, when the elongate member extendsthrough the carrier lumen and across the first notch, and when theelongate member secures the first portion to the carrier member, thefirst free end lies outside the first projection and/or the boundary. Insome embodiments, the elongate member is configured to move axiallythrough the carrier lumen such that the elongate member permits releaseof the first portion from the carrier member and expansion of at leastpart of the expandable member.

In some embodiments, the carrier member has a cross-sectional areacomprising a first half and a second half that are separated by a linesegment intersecting a point along a long axis of the carrier member. Insome embodiments, the carrier lumen intersects solely the first half. Insome embodiments, when the first portion is secured to the carriermember, the first portion intersects solely the first half.

According to certain embodiments, the device further comprises a secondnotch in the carrier member. When the carrier member is positioned inthe luminal structure, the carrier lumen is in fluid communication witha body fluid in the luminal structure at the second notch. The boundaryhas a second discontinuity at the second notch, between a third boundaryend and a fourth boundary end. The elongate member extends through thecarrier lumen and across the second notch. A second projection, having across-sectional shape that is substantially the same as the boundarycross-sectional shape, extends from the third boundary end, across thesecond discontinuity, to the fourth boundary end. The expandable membercomprises a second portion comprising a second free end, the secondportion fitting within the second notch. In some embodiments, when theelongate member extends through the carrier lumen and across the secondnotch, and when the elongate member secures the second portion to thecarrier member, the second free end lies outside the second projectionand/or the boundary. In some embodiments, the elongate member isconfigured to move axially through the carrier lumen, after the firstportion is released from the carrier member, such that the elongatemember permits release of the second portion from the carrier member andrelease of the expandable member from the carrier member.

In some embodiments, when the second portion is secured to the carriermember, the second portion intersects solely the first half. In someembodiments, when the elongate member secures at least one of the firstportion and the second portion to the carrier member, the elongatemember lies exterior to at least one of the first portion and the secondportion relative to the central long axis of the carrier member. In someembodiments, the first projection is collinear with the boundary.

According to certain embodiments, the elongate member is configured tobe refracted by an operator such that the elongate member permits therelease of the first portion. The elongate member permits the release ofthe first portion when the elongate member does not fully extend acrossthe first notch. In some embodiments, the elongate member comprises awire. When expanded within and engaging the luminal structure, theexpandable member substantially reduces flow of the body fluid throughthe luminal structure. In some embodiments, the expandable member fullyobstructs flow of the body fluid through the luminal structure.

According to certain embodiments, the expandable member is helicallyarranged about the carrier member. The expandable member is coiledaround the carrier member before being released from the carrier member.In some embodiments, the device further comprises a catheter throughwhich the carrier member moves when being positioned within the luminalstructure. In some embodiments, when the elongate member secures thefirst portion to the carrier member, the elongate member lies exteriorto the first portion relative to a central long axis of the carriermember.

Additional features and advantages of the invention will be set forth inthe description below, and in part will be apparent from thedescription, or may be learned by practice of the invention. Theadvantages of the invention will be realized and attained by thestructure particularly pointed out in the written description and claimshereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate aspects of the invention andtogether with the description serve to explain the principles of theinvention.

FIG. 1 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, in accordance with variousembodiments of the subject technology.

FIG. 2 illustrates a detailed view of the example of FIG. 1, inaccordance with various embodiments of the subject technology.

FIG. 3A illustrates a cross sectional view of the example of FIGS. 1 and2, taken along line 3-3 of FIG. 2, and having a first portion of anexpandable member fitting in a first notch of a carrier member and anelongate member extending across the first notch, in accordance withvarious embodiments of the subject technology.

FIG. 3B illustrates a perspective view of an example of a first portionof an expandable member fitting in a first notch of a carrier member, inaccordance with various embodiments of the subject technology.

FIG. 4 illustrates a detailed view of the example of FIGS. 1-3A, showingthe first portion of the expandable member in the first notch, inaccordance with various embodiments of the subject technology.

FIG. 5 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, having a catheter and a firstportion of an expandable member fitting in a first notch of a carriermember and an elongate member extending across the first notch, inaccordance with various embodiments of the subject technology.

FIG. 6 illustrates a catheter with a core and guide wire in a luminalstructure of a patient, in accordance with various embodiments of thesubject technology.

FIG. 7 illustrates the catheter of FIG. 6, with the core and guide wireremoved, in accordance with various embodiments of the subjecttechnology.

FIG. 8 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, having a carrier member, withan expandable member fitting in a first notch and a second notch of thecarrier member, and having an occlusion membrane positioned thereabout,in accordance with various embodiments of the subject technology.

FIG. 9 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, having a carrier member, withan expandable member fitting in a first notch and a second notch of thecarrier member, and having an occlusion membrane positioned thereabout,positioned in the luminal structure, and extending from a catheter, inaccordance with various embodiments of the subject technology.

FIG. 10 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, positioned in the luminalstructure, and extending from a catheter in the luminal structure, inaccordance with various embodiments of the subject technology.

FIG. 11 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, expanded in the luminalstructure, in accordance with various embodiments of the subjecttechnology.

FIG. 12 illustrates an example of a device for reducing or stopping flowthrough a luminal structure in a patient, expanded within and engagingthe luminal structure, with a carrier member removed, in accordance withvarious embodiments of the subject technology.

FIG. 13 illustrates an example of a carrier member having slots, inaccordance with various embodiments of the subject technology.

FIG. 14 illustrates an example of a carrier member having a tapered cut,in accordance with various embodiments of the subject technology.

FIG. 15 illustrates an example of a device having an expandable membercovered by an occlusion membrane, in accordance with various embodimentsof the subject technology.

FIG. 16 illustrates an example of a device having an expandable membercovered by an occlusion membrane, in accordance with various embodimentsof the subject technology.

FIG. 17 illustrates an example of a method for reducing or stopping flowthrough a luminal structure in a patient, in accordance with variousembodiments of the subject technology.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the present invention. It willbe apparent, however, to one ordinarily skilled in the art that thepresent invention may be practiced without some of these specificdetails. In other instances, well-known structures and techniques havenot been shown in detail so as not to obscure the present invention.

FIGS. 1-4 illustrate an example of device 10 for delivering expandablemember 12 to luminal structure 14 (illustrated in FIGS. 9-12) in apatient to reduce or stop flow through luminal structure 14, inaccordance with various embodiments of the subject technology. Device 10comprises carrier member 16, positionable in luminal structure 14 in thepatient. Referring to FIGS. 3A and 3B, carrier member 16 hascross-sectional area 18 comprising first half 20 and second half 22 thatare separated by line segment 24 intersecting point 26 along a centrallong axis of carrier member 16. In some embodiments, carrier member 16has carrier lumen 28 extending at least partially through carrier member16 and intersecting solely first half 20. Carrier member 16 has firstnotch 30, wherein, when carrier member 16 is positioned in luminalstructure 14, carrier lumen 28 is in fluid communication with a bodyfluid in luminal structure 14 at first notch 30. First notch 30 may be anotch or ring placed distally at a tip (e.g., about 1-2 mm from the end)of a distal edge of carrier member 16. Carrier member 16 may be nylon,stainless steel hypotube, or any other suitable material. According tocertain embodiments, a proximal end of carrier member 16 is made ofnylon with changeable durometer or stainless steel (optionally slottedfor flexibility) hypotube, and a distal end of carrier member 16 is madeof stainless steel hypotube, about 0.20-0.40″ OD (0.5-1 mm). In someembodiments, carrier member 16 may have a solid cross-sectional areaexcept where carrier lumen 28 extends and/or except where a notch (e.g.,first notch 30) is formed on carrier member 16. For example, wall 31 ofcarrier member 16 may form an inner wall of first notch 30, and may behave a solid cross-sectional area covering at least second half 22. Insome embodiments, wall 31 may have a smaller solid cross-sectional areaprovided that wall 31 forms the inner wall of first notch 30 (e.g., likea table separating a table top area from a table bottom area).

Device 10 also comprises elongate member 32 that extends through carrierlumen 28 across first notch 30 and expandable member 12 configured toexpand within and engage luminal structure 14. Expandable member 12 isconfigured to be carried by carrier member 16 and has first portion 34that fits within first notch 30. Elongate member 32 extends throughcarrier lumen 28 and across first notch 30, securing first portion 34 ofexpandable member 12 to carrier member 16. Elongate member 32 liesexterior to first portion 34, relative to the central long axis ofcarrier member 16 and may be micro welded in place. Elongate member 32is configured to be retracted by an operator, permitting the release offirst portion 34. When elongate member 32 does not fully extend acrossfirst notch 30, elongate member 32 permits the release of first portion34. Elongate member 32 is illustrated as a tungsten wire. However, otherelongated structures, such as ribbon, cable, small diameter hypotube, orother elongated materials may be used. In some embodiments, across-sectional diameter of carrier member 16 may be between 0.018inches and 0.068 inches. In some embodiments, a combined cross-sectionaldiameter of carrier member 16 and elongate member 32 when elongatemember 32 is carried by carrier member 16 may be between 0.018 inchesand 0.068 inches.

In some embodiments, carrier lumen 28 is bounded by boundary 27 having aboundary cross-sectional shape, in accordance with various embodimentsof the subject technology. The boundary cross-sectional shape may be atleast one of an elliptical, rectangular, and polygonal shape. Boundary27 has a first discontinuity at first notch 30, between first boundaryend 27 a and second boundary end 27 b. In some embodiments, firstprojection 29, having a cross-sectional shape that is substantially thesame as the boundary cross-sectional shape, extends from first boundaryend 27 a, across the first discontinuity, to second boundary end 27 b.In some embodiments, elongate member 32 extends through first projection29. In some embodiments, elongate member 32 has a cross-sectional shapethat is substantially the same as the boundary cross-sectional shape. Insome embodiments, elongate member 32 has a cross-sectional area that isless than a cross-sectional area of the boundary cross-sectional shape.In some embodiments, first projection 29 is collinear with boundary 27.First portion 34 comprises free end 35. In some embodiments, whenelongate member 32 extends through carrier lumen 28 and across firstnotch 30, and when elongate member 32 secures first portion 34 tocarrier member 16, first free end 35 lies outside first projection 29and/or boundary 27. In some embodiments, “projection,” as used herein,refers to a shape defining boundaries that has no physicalmanifestation. For example, first projection 29 may be a virtualcylinder and is not an actual physical structure. In some embodiments,“projection,” as used herein, is given its plain ordinary meaning.

According to certain embodiments, carrier member 16 may further comprisesecond notch 36 wherein, when carrier member 16 is positioned in luminalstructure 14, carrier lumen 28 is in fluid communication with a bodyfluid in luminal structure 14 at second notch 36. Elongate member 32 mayextend through carrier lumen 28 across second notch 36 and expandablemember 12 may have second portion 38 that fits within second notch 36.Elongate member 32 extends through carrier lumen 28 and across secondnotch 36, securing second portion 38 of expandable member 12 to carriermember 16. Elongate member 32 lies exterior to second portion 38,relative to the central long axis of carrier member 16 and may be microwelded in place. When second portion 38 of expandable member 12 issecured to carrier member 16, second portion 38 intersects solely firsthalf 20. Elongate member 32 is configured to move axially throughcarrier lumen 28 after first portion 34 of expandable member 12 isreleased from carrier member 16, such that elongate member 32 permitsrelease of second portion 38 from carrier member 16. Such release may bea final or complete release of expandable member 12 from carrier member16. As illustrated in FIG. 1, a single elongate member 32 secures firstportion 34 and second portion 38 of expandable member 12 to carriermember 16 at respective first notch 30 and second notch 36.Alternatively, separate elongate members may be used for each instancewhere a notch is provided in carrier member 16 for engagement withexpandable member 12. For example, a first elongate member may be usedwith first notch 30 to secure first portion 34 of expandable member 12to carrier member 16, while a second elongate member is used with secondnotch 36 to secure second portion 38 of expandable member to carriermember 16. In such an embodiment, the first and second elongate membersmay act completely independently, such that the first elongate memberreleases the first portion 34 and the second releases the second portion38. Such a configuration may allow complete independence of distalrelease from proximal and vice versa. In some such embodiments, thefirst elongate member may be of uniform cross-section, while the secondelongate member may be tapered from proximal to distal, and may serve asan internal kink-resistant support.

Device 10 may also comprise occlusion membrane 40 or other flow reducingmember coupled to expandable member 12 such that when expandable member12 is expanded within and engaging luminal structure 14, expandablemember 12 substantially reduces flow of body fluid through luminalstructure 14. When expandable member 12 is positioned within the lumen,occlusion membrane 40 may substantially reduce or fully obstruct flow ofat least one of emboli and fluid flowing through the lumen. Occlusionmembrane 40 may be secured and placed inside and/or outside ofexpandable member 12. In some aspects, occlusion membrane 40 may becoupled to expandable member 12 using surgical suture.

In some embodiments, expandable member 12 is arranged in a spiral orother helical configuration about carrier member 16. Expandable member12 may be beneficially expanded in a radial direction to engage an innersurface of the lumen. Should the inner surface of the lumen apply aradially compressive force on any portion of expandable member 12, thespiral configuration of expandable member 12 allows for such a force tobe dispersed along the entirety of expandable member 12, therebyproviding strong structural support for expandable member 12 to beplaced within the lumen. In some embodiments, the spiral configurationallows for expandable member 12 to withstand long-term pulsatile loadsof torque and bending, and beneficially reduces risks of fatigue breaks,cracks, etc. In some embodiments, expandable member 12 may be arrangedto have more or less coils in the spiral configuration depending on adesired size a desired placement, and a desired compressibility ofexpandable member 12, and other suitable factors known to those ofordinary skill in the art. In some embodiments, expandable member 12 ishighly flexible while providing sufficient rigidity to be guided throughthe lumen. In some embodiments, tapered distal portion 42 comprises oneto two coils of expandable member 12.

Although expandable member 12 is arranged in the spiral configuration,other suitable configurations known to those of ordinary skill in theart may be used. In some embodiments, expandable member 12 comprises oneor more anchors configured to engage an inner surface of the lumen forresisting axial movement of expandable member 12 when expandable member12 is deployed within the lumen. For example, the one or more anchorsmay be protrusions, or hair-like wires of the same material asexpandable member 12.

According to certain embodiments, device 10 may be removed from withinthe lumen by inverting expandable member 12. For example, an axial forcein the proximal direction may be applied to distal portion 42 such thatdistal portion 42 moves within and toward second portion 38. In someembodiments, such an inversion causes expandable member 12 to “unwind”from its spiral configuration, in which case the axial force maycontinue to be applied until expandable member 12 disengages from theinner surface of the lumen. In some embodiments, expandable member 12may maintain its spiral configuration after the inversion, but otherwisehave a reduced cross sectional dimension as an inverted expandablemember 12. In such a case, the inverted expandable member 12 may beeasily removed from within the lumen because of the reduced crosssectional dimension.

According to various embodiments of the subject technology, expandablemember 12 may comprise at least one of stainless steel, nickel titanium(NiTi), cobalt chromium (CoCr), titanium, a polymer, a polyester basedmaterial, a tyrosine based polycarbonate, a polyethylene based material,Teflon (e.g., including expanded Teflon), and other suitable materialsknown to those of ordinary skill in the art. In some embodiments,expandable member 12 may comprise at least one of polyethylene,polyglicolide, polylactide, ε-caprolactone, polycarbonate,hydroxyalkanote, para dioxinine, polytetrafluoroethylene (PTFE),expanded polytetrafluoroethylene (ePTFE), PLA, PGA, PLLA, PDLLA, PDO,PCL, and other suitable materials known to those of ordinary skill inthe art. In some embodiments, expandable member 12 and/or occlusionmembrane 40 may comprise a bioabsorbable material, beneficially allowingfor their controlled degradation. In some embodiments, expandable member12 and/or occlusion membrane 40 may be formed of bioabsorbable materialto have a controlled degradation anywhere between about 3 months toabout 3 years depending on the desired application of device 10. In someembodiments, the controlled degradation may be less than about 3 monthsor greater than about 3 years. For example, hydrolysis of ester linkagesor effects of enzymatic degradation may be utilized for the controlleddegradation.

In some embodiments, expandable member 12 may be coated with varioussuitable agents to allow expandable member 12 to expand within andengage the inner surface of the lumen. For example, expandable member 12may be coated with biological glue. In some embodiments, the biologicalglue may comprise glue from at least one of crab shells, spider webs,gecko feet, burrowing frogs, mussels, and caulobacter crescentusbacteria. In some embodiments, expandable member 12 may be coated with afriction-resistant coating (e.g., a friction-resistant polymer coating).In some embodiments, radio-opaque markers may be located on carriermember 16, expandable member 12, occlusion membrane 40, elongate member32 and/or catheter 44 for endovascular or other image-guided procedures.For example, a radio-opaque marker may be placed on a first coil ofexpandable member 12. In some embodiments, an outer cross sectionaldimension of the first coil is less than an outer cross sectionaldimension of a second coil of expandable member 12, which will allowspace for the radio-opaque marker to surround, at least in part, anexterior of the first coil. In some embodiments, the first coil isadjacent to the second coil, and occlusion membrane 40 may be coupled tothe second coil. In this regard, having the radio-opaque marker placedon the first coil adjacent to the second coil that is coupled toocclusion membrane 40 will allow an operator of device 10 to identifywhere embolization may occur, for example. In some embodiments, theradio-opaque marker may be a platinum iridium alloy or other suitablemarkers known to those of ordinary skill in the art.

According to various embodiments of the subject technology, occlusionmembrane 40 may be used to occlude, partially or completely, luminalstructure 14 in which device 10 is deployed. In some embodiments as usedherein, occlusion may refer to either partial or complete occlusion. Insome embodiments, occlusion membrane 40 comprises at least one of apolyurethane, a polyanhidrate, PTFE, ePTFE, and other suitable materialsknown to those of ordinary skill in the art. In some embodiments,occlusion membrane 40 may be elastic. In some embodiments, occlusionmembrane 40 may be permeable or non-permeable.

According to certain embodiments, occlusion membrane 40 forms acontinuous cover without a flap. For example, occlusion membrane 40 mayform a cover at distal portion 42. In some embodiments, occlusionmembrane 40 may comprise a plurality of pores each having a diameter ofbetween about 5 microns and about 10 microns, which may be beneficialfor occluding blood, for example. In some embodiments, occlusionmembrane 40 may comprise a plurality of pores each having a diameterless than about 5 microns or greater than about 10 microns. In someembodiments, occlusion membrane 40 may comprise a plurality of poreseach having a diameter less than about 3 microns. In some embodiments,occlusion membrane 40 may comprise a plurality of pores each having adiameter less than about 1 micron. In some embodiments, occlusionmembrane 40 may comprise a plurality of pores each having a diametergreater than about 13 microns. In some embodiments, occlusion membrane40 may comprise a plurality of pores each having a diameter greater thanabout 16 microns. Although occlusion membrane 40 is shown as disposed atdistal portion 42, occlusion membrane 40 may be disposed over otherportions of expandable member 12 depending on the desired placement ofocclusion membrane 40, desired application of device 10, etc. Forexample, occlusion membrane 40 may be disposed over a proximal portionor middle portion of expandable member 12. In another example, occlusionmembrane 40 may be disposed over the proximal portion, middle portion,and distal portion 42.

In some embodiments, a length of expandable member 12 may be betweenabout 7 millimeters (mm) and about 9 mm. In some embodiments, the lengthof expandable member 12 may be less than about 7 mm or greater thanabout 9 mm. According to certain embodiments, a combined length of theproximal portion and the middle portion may be between about 4 mm andabout 5 mm to provide adequate anchoring of expandable member 12 withrespect to distal portion 42 (e.g., between about 40% and about 70% ofthe length of expandable member 12). In some embodiments, the combinedlength of the proximal portion and the middle portion may be less thanabout 4 mm or greater than about 5 mm. In some embodiments, a length ofdistal portion 42 may be between about 3 mm and about 4 mm. In someembodiments, the length of distal portion may be less than about 3 mm orgreater than about 4 mm. In some embodiments, a diameter of the proximalportion and/or the middle portion may be between about 2 mm and about 10mm. In some embodiments, the diameter of the proximal portion and/or themiddle portion may be less than about 2 mm or greater than about 10 mm.In some embodiments, a diameter of distal portion 42 may be betweenabout 0.4 mm and about 0.5 mm. In some embodiments, the diameter ofdistal portion 42 may be less than about 0.4 mm or greater than about0.5 mm.

In some embodiments, an average thickness of occlusion membrane 40 isbetween about 0.0005 inches and about 0.006 inches. In some aspects, theaverage thickness of occlusion membrane 40 may be less than about 0.0005inches or greater than about 0.006 inches. In certain embodiments, anaverage thickness of a distal portion of occlusion membrane 40 isgreater than an average thickness of a proximal portion of occlusionmembrane 40. Such a configuration may ensure that more flow may bereduced at the distal portion of occlusion membrane 40. In someembodiments, the average thickness of the distal portion of occlusionmembrane 40 is between about 0.002 inches and about 0.012 inches. Insome embodiments, the average thickness of the distal portion ofocclusion membrane 40 may be less than about 0.002 inches or greaterthan about 0.012 inches. In some embodiments, the average thickness ofthe proximal portion of occlusion membrane 40 is between about 0.0005inches and about 0.006 inches. In some embodiments, the averagethickness of the proximal portion of occlusion membrane 40 may be lessthan about 0.0005 inches or greater than about 0.006 inches.

According to various aspects of the subject technology, device 10 may beused for various applications for reducing or stopping flow through aluminal structure in a patient. Device 10 may be used for rapid,well-controlled, and reliable occlusion of luminal structures. Forexample, the luminal structure may comprise at least one of a bloodvessel, a body organ, a lung, an airway, a Fallopian tube, a cervicalcanal, a vagina, a cervix, a vas deferens, a bronchus, a ureter, acolon, a rectum, an anus, a bio duct, a pancreatic duct, or othersuitable tubular structures known to those of ordinary skill in the art.In some embodiments, device 10 may be used for temporary occlusion incases of lung disease, or for temporary occlusion of female reproductiveorgans for contraceptive purposes. In some embodiments, device 10 may beremoved, or flow may be restored through the luminal structure torestore original organ functions.

In some embodiments, device 10 may be used for various endoluminalocclusion procedures, including procedures for the lungs (e.g.,selective endobronchial occlusion for lung reduction, occlusion ofbronchopleural or bronchocutaneous fistulas, endovascular occlusion ofpulmonary AVMs and fistulas or aortopulmonary anastomoses) andprocedures for reproductive organs (e.g., endoluminal occlusion of vasdeferens or Fallopian tubes for minimally-invasive contraceptiveintervention, endovascular occlusion of varicocele in males and lowabdominal gonadal veins for reducing or completely eliminating chronicpelvic pain syndrome in females). In some embodiments, device 10 may beused for stopping blood loss from a damaged blood vessel, closing anabnormal blood vessel or a blood vessel supplying a vascular anamaly, orinterrupting blood supply to an organ or part of an organ for permanentdevascularization (e.g., closure of splenic artery in spleen laceration,devascularization of tissues involved by neoplastic process, eitherpre-operatively or as a palliative measure). In some embodiments, device10 may be used for various endovascular (e.g., neural and peripheral)procedures including procedures for giant cerebral and skull baseaneurysms (ruptured and non-ruptured), head and neck arteriovenousfistulas, dissecting intracranial and extracranial vessels, traumaticand non-traumatic vessel injury or rupture (e.g., pelvic hemorrhages intrauma patients, carotid blow-out in patients with head and neckcancers, hemorrhage induced by a neoplasia, etc.), and devascularizationprior to (or as an alternative to) surgical resection of various organsor tumors.

In certain embodiments, device 10 may be used for various organs,including for example, the spleen (e.g., endovascular occlusion as apreoperative intervention or as an alternative to surgical resectionwith indications including traumatic hemorrhage, hypersplenism, bleedingsecondary to portal hypertension or splenic vein thrombosis, and variousdisorders such as thalassemia major, thrombocytopenia, idiopathicthrombocytopenic purpura, Gaucher disease, and Hodgkin disease), theliver (e.g., occlusion of portal veins collaterals as adjunct to atransjugular intrahepatic portosystemic shunt (TIPS), occlusion of theTIPS itself in cases of encephalopathy, occlusion of intrahepaticarterioportal fistulas), the kidney (e.g., endoluminal ureteralocclusion for intractable lower urinary tract fistula with urineleakage, or for the treatment of uretero-arterial fistulae, endovascularocclusion as an alternative to surgical resection for end-stage renaldisease or renovascular hypertension requiring unilateral or bilateralnephrectomy and renal transplant with native kidneys in situ), and theheart (e.g., occlusion of coronary arteriovenous fistulas, transarterialembolization of Blalock-Taussig shunts). The application of device 10 isnot limited to applications for human patients, but may also includeveterinary applications.

In some embodiments, device 10 comprises a tube configured to extendaround or through occlusion membrane 40 to be positioned at a targetsite of the patient. Device 10 also comprises a vacuum source configuredto apply a vacuum through the tube for removing at least one of emboliand fluid from the target site. For example, the tube may be placed in adiseased area that has been subjected to occlusion, and the tube may beused to remove body fluids and/or solid components (e.g., blood clots)from the diseased area.

FIG. 5 illustrates an example of expandable member 12 in the process ofbeing loaded on carrier member 16, in accordance with variousembodiments of the subject technology. As illustrated, second portion 38of expandable member 12 is fitted within second notch 36 and secured inplace by elongate member 32. As first portion 34 of expandable member 12is moved toward first notch 30 to be secured in place by elongate member32, expandable member 12 will extend longitudinally while contractingradially. In addition to longitudinal extension, expandable member 12may also be rotated about carrier member 16 such that expandable member12 is compact enough to fit within catheter 44. Once first portion 34 ofexpandable member 12 is secured in first notch 30, carrier member 16 maybe refracted relative to catheter 44. Carrier member 16, along withexpandable member 12 may move through catheter 44 when being positionedwithin luminal structure 14.

In some aspects, “catheter” as used herein may be given at least itsordinary meaning. In some aspects, “catheter” as used herein may referto any elongate member having a lumen passing therethrough. A catheter,therefore, can be tubular or have other suitable cross sectional shapes,such as at least one of elliptical and polygonal (e.g., triangular,rectangular, hexagonal, octagonal, etc.) cross sectional shapes.Catheter profile can be 4-7 French (or 1.3 to 2.3 mm), or in a range of0.20″ to 0.40″. The length of catheter 44 can be 130-150 cm.

FIG. 6 illustrates an example of catheter 44 in the process of beingpositioned within luminal structure 14 at a deployment site, inaccordance with various embodiments of the subject technology. Catheter44 is introduced into the patient (e.g., via femoral artery) andnavigated through luminal structure 14 and positioned at the deploymentsite. In some embodiments, guide wire 46 is inserted into luminalstructure 14 and has a soft tip useful for reducing trauma and/orfriction. Once guide wire 46 is in place, a guide catheter and/or core48 is introduced, using guide wire 46 as a guide. Core 48 may betelescopically inserted, acting as an independent component, possessinga tapered soft distal tip (about 4-5 mm long) for better trackability ofcatheter 44 through the vascular or any other tortuous tubular system.Core 48 may then be used as a guide for the introduction of catheter 44into luminal structure 14 and for the positioning of catheter 44 at thedeployment site. Thus, a portion of catheter 44 is disposed over aportion of core 48, which is disposed over a portion of guide wire 46.After the position of catheter 44 is evaluated and confirmed at thetarget site (e.g., via flouro imaging), core 48 and guide wire 46 can beremoved. Guide wire 46 may be absent when carrier member 16 andexpandable member 12 with occlusion membrane 40 are introduced. Thus,occlusion membrane 40 may lack a hole for guide wire 46, allowing forenhanced occlusion. In some embodiments, delivery of expandable member12 does not require guide wire 46 to run through occlusion membrane 40,thereby obviating the need to poke a hole through occlusion membrane 40with guide wire 46 for delivery of expandable member 12.

FIG. 7 illustrates an example of a catheter 44 positioned within luminalstructure 14 at a deployment site, in accordance with variousembodiments of the subject technology. Catheter 44 positioned withinluminal structure 14 has an opening therethrough, through which device10 may be introduced, and through which a portion of device 10 may atleast partially emerge from a distal end. In some embodiments, catheter44 may prevent expandable member 12 from radially expanding such thatexpandable member 12 is secured between the inner surface of catheter 44and the outer surface of carrier member 16. In some embodiments, whencarrier member 16 is shifted distally relative to catheter 44 untilexpandable member 12 extends beyond a distal opening of catheter 44 intothe deployment site, catheter 44 no longer prevents expandable member 12from radially expanding. In this regard, expandable member 12 may expandfrom an undeployed configuration into a partially deployed configurationsuch that expandable member 12 partially engages an inner surface of thelumen. In some embodiments, expandable member 12 does not automaticallyexpand into a deployed configuration, but is expanded into the deployedconfiguration via actuation of elongate member 32. In some embodiments,expandable member 12 may be self expandable.

FIG. 8 illustrates an example of device 10 in a position for placementin catheter 44, in accordance with various embodiments of the subjecttechnology. Device 10 comprises carrier member 16, expandable member 12with first portion 34 secured in first notch 30 via elongate member 32,and second portion 38 secured in second notch 36 via elongate member 32.Device 10 also comprises occlusion membrane 40 coupled to an exterior ofexpandable member 12. Expandable member 12 is configured to bepositioned between carrier member 16 and catheter 44 for stowage ofexpandable member 12 before expandable member 12 is deployed withinluminal structure 14. Distal portion 42 of expandable member 12 isloaded into catheter 44 and device 10 is positioned at or near thedeployment site by moving carrier member 16 relative to catheter 44.

FIGS. 9 and 10 illustrate an example of device 10 in a position forexpansion, engagement, and release, in accordance with variousembodiments of the subject technology. Before being released fromcatheter 44, expandable member 12 is coiled around carrier member 16. Ascarrier member 16 and expandable member 12 attached thereto are fedthrough catheter 44, flouro imaging may provide an indication of theposition of carrier member 16. Once the desired position is reached,catheter 44 may be pulled back relative to carrier member 16. In someembodiments, expandable member 12 and occlusion membrane 40 may bedeployed from catheter 44 by shifting carrier member 16 distallyrelative to catheter 44 until expandable member 12 and occlusionmembrane 40 extend beyond a distal opening of catheter 44 into luminalstructure 14. According to various embodiments of the subjecttechnology, expandable member 12 and occlusion membrane 40 may beaccurately deployed and/or repositioned at a deployment site. Forexample, if an operator of device 10 decides that an initial placementof expandable member 12 and occlusion membrane 40 is undesirable, theoperator may redeploy and/or reposition the expandable member 12 andocclusion membrane 40 to another deployment site. In some embodiments,carrier member 16 is configured to shift distally relative to catheter44 until a portion of expandable member 12 extends beyond a distalopening of catheter 44 into a first deployment site for partiallydeploying expandable member 12 from catheter 44. Carrier member 16 isconfigured to shift proximally relative to catheter 44 until the portionof expandable member 12 is retracted proximally into catheter 44 forretracting expandable member 12 into catheter 44. In some embodiments,because a proximal portion of carrier member 16 is still secured toexpandable member 12, expandable member 12 is also retracted oncecarrier member 16 is retracted. Catheter 44 is configured to bepositioned within the lumen at a second deployment site for deployingexpandable member 12 at the second deployment site. Carrier member 16 isconfigured to shift distally relative to catheter 44 until expandablemember 12 extends beyond the distal opening of catheter 44 into thesecond deployment site for deploying expandable member 12 from catheter44 into the second deployment site.

In some embodiments, occlusion membrane 40 may be disposed over distalportion 42 of expandable member 12. According to various embodiments ofthe subject technology, distal portion 42 and occlusion membrane 40 mayextend distally beyond a distal opening of catheter 44 such that whencatheter 44 is moved within the lumen to a deployment site, the distallyextended portion of occlusion membrane 40 is configured to engage a wallof the lumen to reduce friction and potential vessel injury duringdevice tracking and delivery to the deployment site. Thus, the distallyextended portion of occlusion membrane 40 may act as a soft tip whencatheter 44 is being navigated through the lumen and/or positionedwithin the lumen. In such a case, an additional tip may not benecessary. In some embodiments, the distally extended portion ofocclusion membrane 40 may be extended about 2 mm beyond the distalopening of catheter 44. In some embodiments, the distally extendedportion of occlusion membrane 40 may be extended less than about 2 orgreater than about 2 mm beyond the distal opening of catheter 44.

In some embodiments, device 10 further comprises one or more stopsdisposed between catheter 44 and carrier member 16. In some embodiments,a stop is coupled to an inner surface of catheter 44 and is disposedproximal expandable member 12 when expandable member 12 is positionedbetween carrier member 16 and catheter 44. Another stop is coupled to anouter surface of carrier member 16 and is disposed proximal the firststop. In some embodiments, when carrier member 16 is shifted distallyrelative to catheter 44 for deploying expandable member 12, the firststop engages the second stop to substantially prevent carrier member 16from further distal shifting relative to catheter 44.

Once expandable member 12 is positioned and exposed at the deploymentsite, it may be expanded to engage luminal structure 14. First portion34 of expandable member 12 may be released from engagement with carriermember 16 by shifting elongate member 32 distally relative to carriermember 16. Such movement moves elongate member 32 out of first notch 30,allowing first portion 34 of expandable member 12 to move from firstnotch 30, allowing expandable member 12 to expand radially and at leastpartially engage luminal structure 14.

FIG. 11 illustrates an example of device 10 in an at least partiallyexpanded position ready for release, in accordance with variousembodiments of the subject technology. When first portion 34 ofexpandable member 12 has been released, expandable member 12 andocclusion membrane 40 may remain secured to carrier member 16 untilreleased. At this point, device 10 can be safely removed and pulled backinto catheter 44. If full deployment is desired, second portion 38 ofexpandable member 12 may be released from engagement with carrier member16 by shifting elongate member 32 distally relative to carrier member16. Such movement moves elongate member 32 out of second notch 36,allowing second portion 38 of expandable member 12 to move from secondnotch 36, allowing expandable member 12 to disengage or release fromcarrier member 16 completely.

FIG. 12 illustrates an example of expandable member 12 and occlusionmembrane 40 in place in luminal structure 14, in accordance with variousembodiments of the subject technology. Once carrier member 16 isdisengaged from expandable member 12, it can me removed from luminalstructure 14, leaving expandable member 12 and occlusion membrane 40 inplace.

FIG. 13 illustrates an example of carrier member 16 having slots 50, inaccordance with various embodiments of the subject technology. Slots 50may enhance flexibility for better tracking device 10 through tortuousanatomy, while maintaining suitable strength. According to variousembodiments of the subject technology, carrier member 16 may have atleast two slots 50 formed in carrier member 16 by laser cutting or anyother mechanical method.

FIG. 14 illustrates an example of carrier member 16 having tapered cut52, in accordance with various embodiments of the subject technology.Tapered cut 52 may enhance flexibility for better tracking device 10through tortuous anatomy, while maintaining suitable strength. Taperedcut 52, as an example may have dimensions from an exemplary full circleof 0.40″ down to 0.20″ at a distal edge. Thus, tapered cut 52 may have a“c” or half-moon shaped cross section. In addition to slots 50 ortapered cut 52, a system of holes drilled in a portion of carrier member16 may provide flexibility.

FIGS. 15 and 16 illustrate examples of expandable member 12, withocclusion membrane 40 thereon, in accordance with various embodiments ofthe subject technology.

FIG. 17 illustrates an example of method 1700 for delivering anexpandable member to a luminal structure in a patient, in accordancewith various embodiments of the subject technology. Method 1700comprises positioning a carrier member in a luminal structure in apatient (S1702). The carrier member has a cross-sectional area having afirst half and a second half that are separated by a line segmentintersecting a point along a central long axis of the carrier member.The carrier member has a carrier lumen extending at least partiallythrough the carrier member and intersecting solely the first half of thecross-sectional area. The carrier member has a first notch such thatwhen the carrier member is positioned in the luminal structure, thecarrier lumen is in fluid communication with a body fluid in the luminalstructure at the first notch. An elongate member extends through thecarrier lumen across the first notch. An expandable member is carried bythe carrier member and includes a first portion that fits within thefirst notch. The expandable member is configured to expand within andengage the luminal structure such that when the elongate member extendsthrough the carrier lumen and across the first notch, the elongatemember secures the first portion to the carrier member. When the firstportion is secured to the carrier member, the first portion intersectssolely the first half. Method 1700 also comprises moving the elongatemember axially through the carrier lumen such that the elongate memberpermits release of the first portion from the carrier member andexpansion of at least part of the expandable member (S1704). Accordingto various embodiments, the moving may comprise retracting the elongatemember by an operator who is performing the retracting. According tovarious embodiments, method 1700 may further comprise moving the carriermember through a catheter when positioning the carrier member within theluminal structure.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thepresent invention has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the invention.

There may be many other ways to implement the invention. Variousfunctions and elements described herein may be partitioned differentlyfrom those shown without departing from the scope of the invention.Various modifications to these configurations will be readily apparentto those skilled in the art, and generic principles defined herein maybe applied to other configurations. Thus, many changes and modificationsmay be made to the invention, by one having ordinary skill in the art,without departing from the scope of the invention.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations. Aphrase such as an aspect may refer to one or more aspects and viceversa. A phrase such as an “embodiment” does not imply that suchembodiment is essential to the subject technology or that suchembodiment applies to all configurations of the subject technology. Adisclosure relating to an embodiment may apply to all embodiments, orone or more embodiments. A phrase such an embodiment may refer to one ormore embodiments and vice versa.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.” Theterm “some” refers to one or more. All structural and functionalequivalents to the elements of the various configurations describedthroughout this disclosure that are known or later come to be known tothose of ordinary skill in the art are expressly incorporated herein byreference and intended to be encompassed by the invention. Moreover,nothing disclosed herein is intended to be dedicated to the publicregardless of whether such disclosure is explicitly recited in the abovedescription.

What is claimed is:
 1. A system for delivering an expandable member to aluminal structure in a patient, the system comprising: an elongatecarrier member comprising a distal portion, a central axis, and a firstnotch in the distal portion; an engagement component positioned withinthe first notch; and an expandable frame coupled to the distal portionof the carrier member, the expandable frame comprising a first terminalend section that, when coupled to the carrier member, (i) passes from afirst end of the first notch through a space between the central axisand the engagement component and (ii) terminates outside of the firstnotch, beyond a second end of the first notch.
 2. The system of claim 1,wherein the carrier member comprising a lumen extending along thecentral axis thereof, and wherein the first notch extends through thecarrier member to the lumen.
 3. The system of claim 2, wherein theengagement component comprises an elongate wire extending through thelumen.
 4. The system of claim 1, wherein the engagement componentcomprises a wire.
 5. The system of claim 1, wherein the engagementcomponent is configured to be refracted by an operator such that theengagement component permits release of the first terminal end section.6. The system of claim 1, wherein the engagement component permitsrelease of the first terminal end section when the engagement componentdoes not fully extend across the first notch.
 7. The system of claim 1,wherein the expandable frame comprises a spiral configuration and iswound about the carrier member.
 8. The system of claim 1, wherein thefirst terminal end section is substantially straight.
 9. The system ofclaim 1, wherein the engagement component secures the first terminal endsection to the carrier member without being positioned between theexpandable frame and the central axis within a longitudinal extent ofthe first notch along the central axis.
 10. The system of claim 1,further comprising a second notch in the carrier member, the expandableframe comprising a second terminal end section that, when coupled to thecarrier member, (i) passes from a first end of the second notch througha space between the central axis and the engagement component and (ii)terminates outside of the second notch, beyond a second end of thesecond notch.
 11. The system of claim 1, wherein the engagementcomponent moves longitudinally to release the first terminal endsection.
 12. The system of claim 11, wherein the engagement componentmoves longitudinally through a lumen of the carrier member to releasethe first terminal end section.
 13. The system of claim 1, wherein thefirst terminal end section comprises a planar, flat portion.
 14. Anexpandable device for occluding a luminal structure in a patient, thedevice comprising: a helical frame member comprising a plurality ofwindings, proximal and distal segments, and a lumen extending from theproximal segment to the distal segment, the proximal segment having afirst end whereat the frame member changes in curvature and a second endwhereat the frame member terminates, the proximal segment being biasedto extend inwardly into the lumen from a helical arc of the frame memberto facilitate engagement with a delivery system, the distal segmentbeing biased to extend inwardly into the lumen from the helical arc ofthe frame member to facilitate engagement with the delivery system; anda cover member coupled to the helical frame member, the cover memberextending between adjacent windings of the helical frame member.
 15. Thedevice of claim 14, wherein the distal segment comprises a first endwhereat the frame member changes in curvature and a second end whereatthe frame member terminates.
 16. The device of claim 14, wherein theframe member comprises a collapsed configuration in which the framemember has a first, cylindrical configuration and an expandedconfiguration in which the frame member has a second, enlargedconfiguration and the proximal segment of the frame member extendsinwardly into the lumen.
 17. The device of claim 14, wherein in anexpanded configuration, the proximal segment extends inwardly into thelumen through the cover member.
 18. The device of claim 17, wherein inthe expanded configuration, the proximal segment extends into the lumenradially toward a central axis of the frame member.
 19. The device ofclaim 14, wherein the frame member comprises a middle section having acylindrical profile.
 20. The device of claim 14, wherein a radius ofcurvature of the frame member decreases toward the distal segment suchthat the frame member tapers in a distal direction.
 21. The device ofclaim 14, wherein the cover member is coupled to the frame member with asuture.
 22. The device of claim 14, wherein the cover member enclosesthe proximal and distal segments of the frame member.